Devices, systems, and methods for authenticated intravascular device use and reuse

ABSTRACT

Devices, systems, and methods for reconditioning an intravascular device for reuse are provided. The method includes reading first security data from a memory of the intravascular device; determining if the intravascular device is authentic; generating second security data, when the intravascular device is authentic; and writing the second security data to the memory of the intravascular device. Devices, systems, and methods for authenticating an intravascular device for use are also provided. The method includes bringing an intravascular device into communication with a computing device, the intravascular device including a memory; determining if first security data is authentic; determining, when the first security data is authentic, if the intravascular device has been reconditioned; determining, when the intravascular device has been reconditioned, if the second security data is authentic base; and permitting, when second security data is authentic, use of the intravascular device in the clinical procedure.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is continuation of U.S. patent application Ser.No. 15/914,007, filed Mar. 7, 2018, which is a continuation of U.S.patent application Ser. No. 15/269,692, filed Sep. 19, 2016, now U.S.Pat. No. 9,948,466, which is a continuation of U.S. patent applicationSer. No. 14/681,892, filed Apr. 8, 2015, now U.S. Pat. No. 9,445,723,which claims priority to and the benefit of U.S. Provisional ApplicationNo. 61/977,169, filed Apr. 9, 2014, each of which is hereby incorporatedby reference in its entirety.

TECHNICAL FIELD

The present disclosure relates generally to intravascular devices with amemory to implement cryptographic algorithms allowing only authorizeduse and/or reuse of the intravascular devices in clinical procedures.

BACKGROUND

Intravascular devices, such as guide wires, catheters, guide catheters,etc., can be configured for imaging, flow measurement, and/or pressuremeasurement, among other functions. Such intravascular devices aregenerally disposable devices. Further, a manufacturer generally ratesthe intravascular device for a single use. That is, the manufacturerguarantees the safety of the intravascular device and/or the integrityof the data collected using the intravascular device for a single use.After being used within the vasculature of a patient in a clinicalprocedure, the intravascular device is discarded.

Recently, third parties that are not authorized by the manufacturer havecollected used intravascular devices. The used intravascular devices arethen sterilized, repackaged, and sold for future use in clinicalprocedures. This presents significant risk to patients. Theseintravascular devices have not been verified and validated, andtherefore cannot be guaranteed or expected to meet the necessary safetyand efficacy standards of an authentic intravascular device. When anintravascular device is inappropriately reused, it can expose patientsto direct harm via contamination. It can also expose patients to thepossibility of misdiagnosis when a disposable intravascular device isused for a longer time than it was designed to operate safely. Inaddition to patient safety concerns, a manufacturer also suffersfinancial losses when customers purchase repackaged, used intravasculardevices as opposed to authorized ones.

Some efforts have been made previously to ensure that only authorizedintravascular devices are used in clinical procedures. These effortsinclude preventing the use of intravascular devices whose on-board datadid not pass some check conducted by a computing device in the clinicalenvironment. However, third parties have been able to falsify theon-board data so that the computing device treats the intravasculardevice as authentic.

Further, while a third party without detailed knowledge of theintravascular device is unsuited to reprocess or recondition a usedintravascular device, a manufacturer or authorized party is well suitedto do so.

Thus, there remains a need for an authentication system thatcomprehensively prevents the use of unauthorized, fraudulent, and/orotherwise tampered-with intravascular devices. When a manufacturer or anauthorized party reconditions a used intravascular device, theauthentication system also needs to permit the device to be used in aclinical procedure.

SUMMARY

Embodiments of the present disclosure provide an improved securitysystem for intravascular devices by allowing only authorized use and/orreuse during clinical procedures. The intravascular device includes amemory. Cryptography is implemented using the memory. The improvedsecurity also allows a used intravascular device that is properlyreconditioned to be reused in a clinical procedure.

In an exemplary aspect, the present disclosure is directed to a methodof reconditioning an intravascular device for reuse during a clinicalprocedure. The method includes reading first security data from a memoryof the intravascular device; determining if the intravascular device isauthentic based on the first security data; generating second securitydata, when the intravascular device is authentic; and writing the secondsecurity data to the memory of the intravascular device.

In an aspect, the method further includes terminating the reconditioningwhen the intravascular device is determined to be not authentic. In anaspect, the method further includes sterilizing the intravasculardevice. In an aspect, the method further includes evaluating performancecharacteristics of the intravascular device; and generating reuseinstructions for the intravascular device based on the performancecharacteristics. In an aspect, the method further includes reading firstdevice data from the memory of the intravascular device, the firstdevice data including at least one of: a serial number, a manufacturingdate, configuration information, initial parameters, a manufacture date,performance parameters, a version number, an expiration date, and systemconfiguration settings. In an aspect, the method further includesgenerating second device data, the second device including at least oneof: a serial number, additional configuration information, additionalparameters, a recondition date, reuse instructions, performanceparameters, a version number, an expiration date, and systemconfiguration settings; and writing second device data to the memory ofthe intravascular device. In an aspect, the first and second securitydata include a message authentication code. In an aspect, the firstsecurity data is generated using a secret key, the first device data,and the serial number. In an aspect, the second security data isgenerated using a secret key, the second device data, and the serialnumber.

In another exemplary aspect, the present disclosure is directed to anintravascular system. The system includes a computing device incommunication with an intravascular device, the computing device beingconfigured to recondition the intravascular device for reuse during aclinical procedure by: reading first security data from a memory of theintravascular device; determining if the intravascular device isauthentic based on the first security data; generating second securitydata, when the intravascular device is authentic; and writing the secondsecurity data to the memory of the intravascular device.

In an aspect, the computing device is further configured to: evaluateperformance characteristics of the intravascular device; and generatereuse instructions for the intravascular device based on the performancecharacteristics. In an aspect, the computing device is furtherconfigured to: read first device data from the memory of theintravascular device, the first device data including at least one of: aserial number, a manufacturing date, configuration information, initialparameters, a manufacture date, performance parameters, a versionnumber, an expiration date, and system configuration settings; generatesecond device data, the second device data including at least one of: aserial number, additional configuration information, additionalparameters, a recondition date, reuse instructions, performanceparameters, a version number, an expiration date, and systemconfiguration settings; and write second device data to the memory ofthe intravascular device. In an aspect, the computing device is furtherconfigured to generate the second security data by generating a messageauthentication code. In an aspect, the computing device is furtherconfigured to generate the second security data by using a secret key,the second device data, and the serial number.

In another exemplary aspect, the present disclosure is directed to amethod of authenticating an intravascular device for use during aclinical procedure. The method includes bringing an intravascular deviceinto communication with a computing device, the intravascular deviceincluding a memory accessible by the computing device, the memory havingfirst device data, second device data, first security data, and secondsecurity data stored thereon; determining if first security data isauthentic based on the first device data; determining, when the firstsecurity data is authentic, if the intravascular device has beenreconditioned based on the second device data; determining, when theintravascular device has been reconditioned, if the second security datais authentic based on the second device data; and permitting, whensecond security data is authentic, use of the intravascular device inthe clinical procedure.

In an aspect, the method further includes determining if theintravascular device is within an authorized period of use based on atleast one of the first device data and the second device data; andpermitting, when the intravascular device is within the authorizedperiod of use, use of the intravascular device in the clinicalprocedure. In an aspect, the first and second security data include amessage authentication code, wherein the first security data isgenerated using a secret key, the first device data, and a serial numberof the memory, and the second security data is generated using thesecret key, the second device data, and the serial number of the memory.

In another exemplary aspect, the present disclosure is directed to anintravascular system. The system includes a computing device incommunication with an intravascular device having a memory, thecomputing device being configured to authenticate the intravasculardevice for use during a clinical procedure by: determining if firstsecurity data stored on the memory is authentic based on first devicedata stored on the memory; determining, when the first security data isauthentic, if the intravascular device has been reconditioned based onsecond device data stored on the memory; determining, when theintravascular device has been reconditioned, if second security datastored on the memory is authentic based on the second device data; andpermitting, when second security data is authentic, use of theintravascular device in the clinical procedure.

In an aspect, the computing device is further configured to: determineif the intravascular device is within an authorized period of use basedon at least one of the first device data and the second device data; andpermit, when the intravascular device is within the authorized period ofuse, use of the intravascular device in the clinical procedure. In anaspect, the first and second security data include a messageauthentication code, wherein the first security data is generated usinga secret key, the first device data, and a serial number of the memory,and the second security data is generated using the secret key, thesecond device data, and the serial number of the memory.

Additional aspects, features, and advantages of the present disclosurewill become apparent from the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

Illustrative embodiments of the present disclosure will be describedwith reference to the accompanying drawings, of which:

FIG. 1 is a diagrammatic schematic view of an intravascular system in amanufacturing environment according to aspects of the presentdisclosure.

FIG. 2 is a flow diagram of a method of initially conditioning anintravascular device for use during a clinical procedure according toaspects of the present disclosure.

FIG. 3 is a diagrammatic schematic view of an intravascular system in areconditioning environment according to aspects of the presentdisclosure.

FIG. 4 is a flow diagram of a method of reconditioning an intravasculardevice for reuse during a clinical procedure according to aspects of thepresent disclosure.

FIG. 5 is a diagrammatic schematic view of an intravascular system in aclinical environment according to aspects of the present disclosure.

FIG. 6 is a flow diagram of a method of authenticating an intravasculardevice for use and/or reuse during a clinical procedure according toaspects of the present disclosure.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It is nevertheless understood that no limitation tothe scope of the disclosure is intended. Any alterations and furthermodifications to the described devices, systems, and methods, and anyfurther application of the principles of the present disclosure arefully contemplated and included within the present disclosure as wouldnormally occur to one skilled in the art to which the disclosurerelates. In particular, it is fully contemplated that the features,components, and/or steps described with respect to one embodiment may becombined with the features, components, and/or steps described withrespect to other embodiments of the present disclosure. For the sake ofbrevity, however, the numerous iterations of these combinations will notbe described separately.

The devices, systems, and methods described herein relate toauthenticated use and/or reuse of an intravascular device. Theintravascular device includes a memory. The authentication schemedescribed herein implements encryption using the memory. Authenticationcan be accomplished using one or more cryptographic codes written to thememory of the intravascular device. The authentication scheme describedherein uses data about the intravascular device stored on the memory aswell as the cryptographic codes to comprehensively prevent unauthorizeddevice use and/or reuse. New data (e.g., about the intravascular deviceand/or cryptographic codes) can be written to the memory to furthersecure the intravascular device. For example, new data can be written tothe memory before, during, and/or after use, reuse, sterilization,and/or reconditioning of the intravascular device. A computing device inthe clinical environment and/or a remote computing device can use thedata about the intravascular device and/or the cryptographic codes toverify that the intravascular device is authentic and authorized to beused during the clinical procedure.

The authentication algorithm described herein prevents the use of anexpired and/or unauthorized intravascular device by verifying theintegrity and status of the intravascular device before use. Anintravascular device can be unauthorized when the device is beingimproperly reused or because the device is an unauthorized clone of themanufacturer's device. The cryptography implemented as part of thememory of the intravascular device makes it computationally infeasibleto forge a valid intravascular device such that it would be incorrectlytreated as authentic.

The devices, systems, and methods described herein can apply to anydisposable or limited use intravascular device, include devicesconfigured for intravascular ultrasound (IVUS), optical coherencetomography (OCT), forward-looking IVUS (FLIVUS), forward-lookingintra-cardiac echo (FLICE), flow measurements, pressure measurements,and/or combinations thereof.

FIG. 1 is a diagrammatic schematic view of an intravascular system 100in a manufacturing environment, according to aspects of the presentdisclosure. The intravascular system 100 includes an intravasculardevice 102, such as a catheter, guide wire, or guide catheter. In someembodiments, the intravascular device 102 is configured to image a lumenof a blood vessel using one or more imaging modalities (e.g., IVUS, OCT,etc.). In some embodiments, the intravascular device 102 is configuredto measure the pressure and/or flow of blood through the blood vessel.One or more components for imaging, pressure measurement, and/or flowmeasurement can be positioned at a distal portion of the intravasculardevice 102.

The intravascular device 102 includes a memory 104. The memory 104 canbe a write-once memory or a rewritable/reprogrammable memory. Forexample, with a rewritable/programmable memory, portions of the memory104 can be rewritten or reprogrammed, after being initially programmed,without degradation of the memory and/or the intravascular device 102.In various embodiments, the memory 104 can be Electrically ErasableProgrammable Read-Only Memory (EEPROM), flash memory, hard disk, and/orother suitable storage. The memory 104 has sufficient capacity to storedata about the intravascular device 102 (e.g., unique serial number ofthe memory 104, configuration information, initial parameters, reuseinstructions, manufacturing data, reprocessing data, clinical use data,etc.) as well as security or cryptographic data (e.g., one or moremessage authentication code(s)).

The intravascular device 102 is a disposable or limited use device. Forexample, a manufacturer can guarantee the safety of the intravasculardevice 102 and/or the integrity of the data collected using theintravascular device 102 for one, two, three, four, or more limitednumber of uses. The intravascular device 102 can also be a reusabledevice that is sterilizable (e.g., using autoclave procedures) betweenuses. Thus, the intravascular device 102 can be used in multipleprocedures. In some embodiments, the intravascular device 102 isreusable after only being sterilized. In some embodiments, theintravascular device 102 is reusable after being reconditioned (e.g.,after being both sterilized and undergoing further processing to preparethe intravascular device 102 for reuse). An exemplary embodiment of areconditioning procedure is discussed with respect to FIGS. 3 and 4. Theintravascular device 102 can be configured for use and/or reuse within aspecified period of time after manufacture and/or reconditioning.

FIG. 1 illustrates a manufacturing environment in which theintravascular device 102 is initially assembled, conditioned, and/orprogrammed. Data about the intravascular device can be written to thememory 104 by the manufacturing system 110. The manufacturing system 110includes a computing device configured to be in communication with theintravascular device 102 and to program the intravascular device 102with the initial parameters, the security data, and other suitable datato allow the intravascular device 102 to be used in a clinicalenvironment. An exemplary embodiment of an initial conditioningprocedure is discussed with respect to FIG. 2.

The manufacturing system 110 can be configured to directly access, read,and/or write the memory 104. In a manufacturing environment, thecommunication of signals between the manufacturing system 110 and theintravascular device 102 can include transferring the initialparameters, the security data, and other suitable data from themanufacturing system 110 to the intravascular device 102. In someembodiments, the manufacturing system 110 does not directly access thememory 104, and rather, an additional component (e.g., similar to thepatient interface module (PIM) 520 of FIG. 5) facilitates communicationbetween the manufacturing system 110 and the intravascular device 102.In some embodiments, the functionality of the additional component isperformed by the manufacturing system 110 and/or the intravasculardevice 102 such that the additional component is not utilized.

FIG. 2 is a flow diagram of method 200 of initially conditioning anintravascular device for use during a clinical procedure, according toaspects of the present disclosure. One or more steps of the method 200can be carried out by the manufacturing system 110 to prepare theintravascular device 102 for use in a patient's vasculature. As a resultof the method 200, the intravascular device 102 can be implemented alongwith an authentication algorithm to allow only authorized use and/orreuse of the intravascular device 102.

At step 202, the method 200 includes generating first device data. Firstdevice data can include, e.g., a unique serial number of the memory 104,configuration information, initial parameters, a manufacture date,performance parameters, a version number, an expiration date, systemconfiguration settings, and other data about the intravascular device102. The first device data can be generated based on the particularcomponents of the intravascular device 102, including the memory 104 andthe component(s) for imaging, pressure measurement, and/or flowmeasurement. In some embodiments, the factory-/manufacturing-providedunique serial number can be written on a read-only memory (ROM) portionof the memory 104.

At step 204, the method 200 includes writing the first device data tothe memory 104. For example, the intravascular device 102 can be broughtinto communication with the manufacturing system 110 such that themanufacturing system 110 can access and program the memory 104. Thefirst device data can be written to specified portions of the memory 104(e.g., pages 0 and 1).

At step 206, the method 200 includes generating first security data. Insome embodiments, the first security data (as well as a second, third,fourth, and other security data) can include a message authenticationcode (MAC) or other suitable cryptographic tool such as hash functions,block ciphers, etc. In some embodiments, the first security data isgenerated using the first device data, the unique serial number of thememory 104, and a secret key 208 as input. The secret key 208 can be aparameter used in the authentication algorithm that is known only to themanufacturer of the intravascular device 102 or an authorized party.

In an exemplary embodiment, the authentication algorithm utilizes acipher-based message authentication code (CMAC) or one-key CBC MAC1(OMAC1) with the 128-bit advanced encryption standard (AES). Anexemplary authentication algorithm is described in The Internet Society,The AES-CMAC Algorithm (2006), available athttp://tools.ietf.org/html/rfc4493, the entirety of which is herebyincorporated reference. In various embodiments, other suitableauthentication schemes, such as the data authentication algorithm (DAC),cipher block chaining message authentication code (CBC-MAC), keyed-hashmessage authentication code (HMAC), parallelizable MAC (PMAC), VMAC,message authentication code based on universal hashing (UMAC),Poly1305-AES, etc., may be utilized.

One or more MACs for the devices, systems, and methods described hereincan be generated as follows for a CMAC-based authentication algorithm.Let k denote a 128-bit key chosen uniformly at random by themanufacturer as the secret key, and let k₁, k₂ be 128-bit subkeysderived from k as output of the GenerateSubKey algorithm below. LetE_(k)(x) and E_(k) ⁻¹ (x) be the 128-bit AES encryption and decryptionfunctions respectively on a 128-bit string x using key k. Let msb₁(x)denote the most significant (or left-most) bits of x or the mostsignificant bit if 1 is omitted. Left shift is denoted by << andexclusive-or by ⊕.

The GenerateSubKey algorithm can be defined as set forth below. TheGenerateSubKey algorithm can take a 128-bit (16-byte) string and returntwo 128-bit strings to be used as subkeys in the GenerateMac algorithm.

  GenerateSubKey (k:uint128):(uint128, uint128) C ← (uint128)0x87 k₀ ←E_(k)((unit128)0) if msb(k₀) = 0  k₁ ← k₀ << 1 else  k₁ ← (k₀ << 1) ⊕ Cif msb(k₁) = 0  k₂ ← k₁ << 1 else  k₂ ← (k₁ << 1) ⊕ C return (k₁,k₂)

The GenerateMac algorithm can be defined as set forth below. TheGenerateMac algorithm utilizes the 128-bit key k, a byte array Dcontaining a message to generate a CMAC, and the length n in bytes of D.The return value is the 128-bit CMAC.

  GenerateMac (k:uint128, D:byte[n], n:int):uint128 (k₁, k₂) ←GerateSubKey(k) if n = 0  return ERROR m ← fn/16     {m is the number ofblocks to process} B:unit128[m]   {B is the message as 16-byte blocks}for i in [0,m − 1]  B[i] ← D[i * 16] if n ≡ 0 (mod 16)  B [m − 1] ← B[m− 1]⊕k₁ else {pad the last block with bits 100...00}  lastBlock:uint128 lastBlock ← D[((m − 1) * 16) ... n] 0x80 0^(16−(n−16{m−1))−1)  B[m − 1]← lastBlock⊕k₂ x ← (unit128)0 for i in [0,m - 1]  y ← x ⊕ B[i] x ←E_(k)(y) return x

At step 210, the method 200 includes writing the first security data tothe memory 104. The first security data can be written to a specifiedportion of the memory 104 (e.g., page 1).

At step 212, the method 200 includes preventing editing of theportion(s) of the memory 104 with the first device data and the firstsecurity data. For example, the memory 104 can include a lock pagefunctionality that locks specified portions of the memory 104 andprevents those portions from being edited.

After being initially conditioned based on the method 200, theintravascular device and the authentication algorithm can be implementedin a clinical environment as described with respect to FIGS. 5 and 6.After one or more uses, the intravascular device can be reconditioned bythe manufacturer or authorized party for subsequent uses. This isdescribed with respect to FIGS. 3 and 4.

FIG. 3 is a diagrammatic schematic view of an intravascular system 300in a reconditioning environment, according to aspects of the presentdisclosure. FIG. 3 illustrates a reconditioning environment in which theintravascular device 102 is prepared for reuse, after the intravasculardevice 102 has been used in one or more clinical procedures. A computingdevice (e.g., a reconditioning system 310) can evaluate performancecharacteristics of the intravascular device 102 to identify any changesresulting from earlier uses and generate reuse instructions thatcompensate for the identified changes. The reconditioning system 310 canalso write second security data, a recondition date, etc., to the memory104 such that a clinical system will recognize that the intravasculardevice 102 has been properly reconditioned and permit reuse. In someembodiments, the reconditioning system 310 can be configured to directlyaccess, read, and/or write the memory 104. In some embodiments, themanufacturing system 110 does not directly access the memory 104, andrather, an additional component facilitates communication between themanufacturing system 110 and the intravascular device 102. In someembodiments, the reconditioning system 310 can be the manufacturingsystem 110 (FIG. 1). For example, the manufacturing system 110 can beconfigured to perform the initial conditioning procedure described withrespect to FIG. 2 and the reconditioning procedure described withrespect to FIG. 4.

FIG. 4 is a flow diagram of a method 400 of reconditioning anintravascular device for reuse during a clinical procedure according toaspects of the present disclosure. One or more steps of the method 400can be carried out by the manufacturer or an authorized party using thereconditioning system 310. As a result of the method 400, theintravascular device 102 can be implemented along with an authenticationalgorithm to allow only authorized reuse of the reconditionedintravascular device 102 in a clinical environment.

At step 402, the method 400 includes reading the first device dataand/or the first security data from the memory 104. At step 404, themethod 400 includes determining if the intravascular device 102 isauthentic. For example, the reconditioning system 310 can determine thatthe intravascular device 102 is authentic using the authenticationalgorithm described herein. Using the first device data read from thememory 104 (step 402), the reconditioning system 310 can determine thatthe first security data read from the memory 104 (step 402) isauthentic. If the intravascular device 102 is not authentic, at step406, the method 400 can include terminating the reconditioningprocedure. Such circumstances can arise, for example, when theintravascular device 102 was not initially conditioned by themanufacturer, the memory 104 was tampered with, etc. In suchcircumstances, use of the intravascular device 102 may present a healthrisk to the patient, and the intravascular device 102 can be discarded.In some embodiments, additional processing can be performed if theintravascular device is not authentic to remove the health risks to thepatient, re-authenticate the intravascular device, etc. In suchembodiments, an intravascular device that is determined to beinauthentic is not discarded and undergoes the reconditioning procedure.

When the intravascular device 102 is authentic, at step 408, the method400 includes determining if an initial use date field of the memory 104is blank. Such circumstances can arise, for example, when anintravascular device 102 that has not been previously used is introducedto the reconditioning environment. The initial use field of the memory104 can also be blank when an intravascular device 102 is previouslyused but the initial use field was not populated by a computing devicein the clinical environment through some error. Even though non-standardevents can cause the initial use date field to be blank, those eventsare not likely to require termination of the reconditioning procedurebecause the authenticity of the intravascular device (step 404) hasalready been verified. When the initial use date field is blank, at step410, a placeholder initial use date can be written to a specifiedportion of the memory 104 (e.g., page 3).

When the initial use date field has been populated with a placeholder orwhen the initial use date field is not blank, at step 412, the method400 can include generating second device data. In some embodiments, thesecond device data can include all or some portion of the of the firstdevice data. The second device data can include a serial number,additional configuration information, additional parameters, arecondition date, reuse instructions, performance parameters, a versionnumber, an expiration date, system configuration settings, and otherdata about the intravascular device 102.

In some embodiments, the method 400 can include evaluating performancecharacteristics of the intravascular device (e.g., one or morecomponent(s) of the intravascular device 102 for imaging, pressuremeasurement, and/or flow measurement). The performance of theintravascular device 102 can degrade as a natural result of use. Themethod 400 can thus include generating reuse instructions generatedbased on the performance characteristics. The reuse instructions can,for example, specify how data collected by the intravascular device 102should be processed in the clinical environment. The reuse instructionscan be a modification of how the data was processed during an initialuse and can compensate for any degradation of the intravascular device102. At step 414, the method 400 includes writing the second device datato the memory 104. The second device data can be written to specifiedportion(s) of the memory 104 (e.g., page 2).

At step 416, the method 400 includes generating second security data. Insome embodiments, the second security data can include a second MAC. Thesecond MAC can be generated in a similar manner as the first MACdescribed above. For example, the second MAC can be generated using thesecond device data, all or some portion of the first device data, theunique serial number of the memory 104, and the secret key 208 as input.At step 420, the method 400 includes writing the second security data tothe memory 104. The second security data can be written to a specifiedportion of the memory 104 (e.g., page 2). In some embodiments, thesecond security data replaces the first security data. For example, thespecified portion of the memory 104 including the first MAC is rewrittento include the second MAC. In some embodiments, the memory 104 includesboth the first security data and the second security data. At step 422,the method 400 includes preventing editing of the portion(s) of thememory 104 with the second device data and the second security datausing the lock page functionality of the memory 104.

After being reconditioned based on the method 400, the intravasculardevice and the authentication algorithm can be implemented in a clinicalenvironment as described with respect to FIGS. 5 and 6.

FIG. 5 is a diagrammatic schematic view of an intravascular system 500in a clinical environment, according to aspects of the presentdisclosure. FIG. 5 illustrates a clinical environment in which theintravascular device 102 is used and/or reused during a clinicalprocedure. For example, the intravascular device 102 can be used with aclinical system 510 for intravascular imaging, pressure measurement,and/or flow measurement. The clinical system 510 can include a computingdevice in communication with the intravascular device 102 and configuredto determine if the intravascular device 102 is authenticated for useand/or reuse.

The clinical system 510 and the intravascular device 102 can be incommunication a patient interface module (PIM) 520 in some embodiments.The PIM 520 facilitates communication of signals between the clinicalsystem 510 and the intravascular device 102. In some embodiments, thePIM 520 supplies high- and low-voltage DC power to support operation ofthe intravascular device 102, including the component(s) for imaging,pressure measurement, and/or flow measurement. In some embodiments, thePIM 520 is configured to access, read, and/or write the memory 104 basedon, e.g., instructions from the clinical system 510. In otherembodiments, the clinical system 510 is configured to directly access,read, and/or write the memory 104 without the PIM 520.

FIG. 6 is a flow diagram of a method 600 of authenticating anintravascular device for use and/or reuse during a clinical procedureaccording to aspects of the present disclosure. One or more steps of themethod 600 can be carried out by using the clinical system 510. Themethod 600 can allow for authenticated initial use of the intravasculardevice 102, authenticated reuse of the intravascular device 102,authenticated initial use of a reconditioned intravascular device 102,and/or authenticated reuse of the reconditioned intravascular device102.

At step 602, the method 600 includes bringing the intravascular device102 into communication with the PIM 520 and/or the clinical system 510.For example, a catheter can be physically inserted into the PIM 520. Inother embodiments, the intravascular device 102 wirelessly communicateswith the PIM 520 and/or the clinical system 510.

At step 604, the method 600 includes determining if the first securitydata is authentic. For example, the clinical system 510 can determine ifthe first MAC is authentic using the first device data. If the firstsecurity data is not authentic, the intravascular device 102 isdetermined to be unauthorized for use. The first security data can beinauthentic when, for example, the data of the memory 104 is forgedand/or otherwise tampered with. When the first security data is notauthentic, at step 606, the method 600 includes providing an indicationto a user that the intravascular device 102 is unauthorized for clinicaluse. The clinical system 510 can also write a diagnostic code to thememory 104 indicating that the intravascular device 102 is unauthorizedbecause the security data is not authentic. For example, the clinicalsystem 510 will modify a first unused use date field of the memory 104,write the serial number of the clinical system 510 to the memory 104,and/or write the diagnostic code to the memory 104. Future attemptedreuse of the unauthorized intravascular device 102 can be prevented whena clinical system reads the diagnostic code. At step 608, the method 600includes denying use of the intravascular device 102.

When the first security data is authentic, at step 610, the method 600includes determining if the initial use date field of the memory 104 hasbeen modified. When the initial use date field has not been modified,the clinical system 510 determines that the intravascular device 102 isa new, unused device. To determine if the intravascular device 102 isauthorized for initial use, at step 612, method 600 includes determiningif the intravascular device 102 has expired. Step 612 can includereading the manufacture date field and/or an authorized period of usefield from the memory 104. The clinical system 510 can determine if acurrent date, compared to the manufacture date, is within authorizedperiod of use. If the intravascular device 102 is determined to beexpired, then the intravascular device 102 is not authorized. At step614, the method 600 includes providing an indication to a user that theintravascular device 102 is unauthorized for clinical use. The clinicalsystem 510 can also write a diagnostic code to the memory 104 indicatingthat the intravascular device 102 is unauthorized because theintravascular device 102 has expired. For example, the clinical system510 will modify a first unused use date field of the memory 104, writethe serial number of the clinical system 510 to the memory 104, and/orwrite the diagnostic code. Future attempted reuse of the unauthorizedintravascular device 102 can be prevented when a clinical system readsthe diagnostic code. At step 608, the method 600 includes denying use ofthe intravascular device 102.

When the intravascular device 102 has not expired, the clinical system510 determines that the intravascular device 102 is authorized forinitial use. At step 616, the method 600 includes writing the currentdate to the initial use date field of the memory 104. Step 616 can alsoinclude writing the serial number of the clinical system 510 to thememory 104 as further information regarding use of the intravasculardevice 102. At step 618, the method 600 includes allowing use of theintravascular device 102.

If the clinical system 510 determines, at step 610, that the initial usedate field of the memory 104 has been modified, then, at step 620, themethod 600 includes determining if the intravascular device 102 has beenreconditioned or reprocessed. For example, the clinical system 510 candetermine if second device data has been written to the memory 104, if areprocessing date field of the memory 104 has been populated, etc. Whenthe intravascular device 102 has not been reconditioned, the clinicalsystem 510 determines that the intravascular device 102 is being reused.At step 622, the method 600 includes determining if the intravasculardevice 102 is within a period of time authorized for reuse (e.g., areuse window). Step 622 can include reading the manufacture date field,the initial use date field, and/or an authorized period of reuse fieldfrom the memory 104. The clinical system 510 can determine if a currentdate, compared to the manufacture date and/or the initial use date, iswithin the authorized period of reuse. If reuse is attempted outside ofthe period authorized for reuse, then the intravascular device 102 isnot authorized. At step 624, the method 600 includes providing anindication to a user that the intravascular device 102 is unauthorizedfor clinical use. The clinical system 510 can also write a diagnosticcode to the memory 104 indicating that the intravascular device 102 isunauthorized because the reuse window for the intravascular device 102has expired. For example, the clinical system 510 will modify a firstunused use date field of the memory 104, write the serial number of theclinical system 510 to the memory 104, and/or write the diagnostic code.Future attempted reuse of the unauthorized intravascular device 102 canbe prevented when a clinical system reads the diagnostic code. At step608, the method 600 includes denying use of the intravascular device102.

When the intravascular device 102 is within the reuse window, theclinical system 510 determines that the intravascular device 102 isauthorized for reuse. The method 600 can include writing the currentdate to the reuse date field of the memory 104. Method 600 can alsoinclude writing the serial number of the clinical system 510 to thememory 104 as further information regarding reuse of the intravasculardevice 102. At step 618, the method 600 includes allowing use of theintravascular device 102.

If the clinical system 510 determines, at step 620, that theintravascular device 102 has been reconditioned or reprocessed, then, atstep 626, the method 600 includes determining if the second securitydata is authentic. For example, the clinical system 510 can determine ifthe second MAC is authentic using the second device data. In someembodiments, the second MAC is determined to be authentic using all orsome portion of the first device data and/or the second device data. Ifthe second security data is not authentic, the intravascular device 102is determined to be unauthorized. Similar to the first security data,the second security data can be determined to be not authentic when, forexample, the data of the memory 104 is forged and/or otherwise tamperedwith. When the second security data is not authentic, at step 606, themethod 600 includes providing an indication to a user that theintravascular device 102 is unauthorized for clinical use, as describedabove. At step 608, the method 600 includes denying use of theintravascular device 102.

When the second security data is authentic, at step 628, the method 600includes determining if a reconditioned or reprocessed use date field ofthe memory 104 has been modified. When the reconditioned use date fieldhas not been modified, the clinical system 510 determines that theintravascular device 102 is device that has not been used since beingreconditioned. To determine if the intravascular device 102 isauthorized for initial use after being reconditioned, at step 630,method 600 includes determining if the intravascular device 102 hasexpired. Step 630 can include reading the manufacture date field, arecondition date field, and/or an authorized period of use field fromthe memory 104. The clinical system 510 can determine if a current date,compared to the manufacture date and/or the recondition date, is withinthe authorized period of use. If the intravascular device 102 isdetermined to be expired, the intravascular device 102 is notauthorized. At step 614, the method 600 includes providing an indicationto a user that the intravascular device 102 is unauthorized for clinicaluse, as described above. At step 608, the method 600 includes denyinguse of the intravascular device 102.

When it is determined at step 630 that the intravascular device 102 hasnot expired, the clinical system 510 determines that the intravasculardevice 102 is authorized for initial use after reconditioning. At step632, the method 600 includes writing the reconditioned use date to thememory 104. Step 632 can also include writing the serial number of theclinical system 510 to the memory 104 as further information regardinguse of the intravascular device 102. At step 618, the method 600includes allowing use of the intravascular device 102.

If, at step 628, the reconditioned use date field of the memory 104 hasbeen modified, then the clinical system 510 determines that thereconditioned intravascular device 102 is being reused. At step 622, themethod 600 includes determining if the intravascular device 102 iswithin a period of time authorized for reuse. Step 622 can includereading the manufacture date field, the initial use date field, thereconditioned use date field, and/or an authorized period of reuse fieldfrom the memory 104. The clinical system 510 can determine if a currentdate, compared to the manufacture date, the initial use date, and/or thereconditioned use date, is within the authorized period of reuse. Ifreuse is attempted outside of the period authorized for reuse, then theintravascular device 102 is not authorized. At step 624, the method 600includes providing an indication to a user that the intravascular device102 is unauthorized for clinical use, as described above. At step 608,the method 600 includes denying use of the intravascular device 102.

When, at step 622, the intravascular device 102 is within the reusewindow, the clinical system 510 determines that the reconditionedintravascular device 102 is authorized for reuse. The method 600 caninclude writing a reuse date to the memory 104. Method 600 can alsoinclude writing the serial number of the clinical system 510 to thememory 104 as further information regarding reuse of the reconditionedintravascular device 102. At step 618, the method 600 includes allowinguse of the intravascular device 102.

While the method 600 describes one instance of reuse and one instance ofreconditioning, it is understood that the intravascular device 102 canbe reused and/or reconditioned one, two, three, four, or more times. Assuch, third, fourth, and other device data and/or security data can bewritten to the memory 104. The intravascular device 102 can beauthenticated for use in a similar manner as described with respect tothe method 600.

The devices, systems, and methods described herein use MACs to preventforgery and detect errors in the data stored on the memory 104. Todetermine if the intravascular device 102 is authentic, the clinicalsystem 510 considers the contents of the memory 104 as an encryptedmessage sent from the manufacturer to the clinical system 510. Theauthentication algorithm allows the intravascular device 102 and/orcomputing devices (e.g., the manufacturing system 110, thereconditioning system 310, and/or the clinical system 510) to be immunefrom one or more forgeries. For example, the authentication algorithmcan prevent a replay attack in which the same message is sent twice andaccepted as authentic both times. This can occur, for example, if theMAC/memory contents from a reconditioned device are copied to a devicethat has yet to be reconditioned. As described above, the memory 104 caninclude, from manufacturing, a ROM with a unique serial number. Byincluding the unique serial number as one of the inputs for generatingthe MAC, the MAC is tied to the specific memory 104 it is written onwith only a negligible chance of collision.

The authentication algorithm can prevent an alteration in which some ofthe message is modified and accepted as authentic. When the memory 104is written during manufacturing or during reconditioning, portions arelocked to prevent any further changes. Additionally, if the values aresomehow changed, an attacker would be unable to generate a new valid MACwithout the secret key 208. To prevent alteration, the MAC can beconfigured such that a single-bit change in the input data causesroughly half the bits in the MAC to change in a manner notcomputationally feasible to predict (e.g., as provided for incryptographic primitives such as block ciphers and hash functions).

The authentication algorithm can prevent a no-message attack in which avalid message/MAC pair is generated based on knowledge of other validmessages (e.g., an adaptive chosen-message attack). The secret key 208is necessary to generate authentic MACs. The secret key 208 remainssecret and is able to be changed as necessary. Such changes can be madecoordination with a manufacturer's software releases for the clinicalsystem 510. For example, the clinical system 510 can have access to anarray of secret keys to authenticate the intravascular device 102, basedon the serial number contained on memory 104. The manufacturer canchange the secret key 208 with each new software release (e.g., for theclinical system 510) and require all newer devices (e.g., with a serialnumber above a cut-off value) to have a MAC based on the new key writtento the memory 104 to be considered authentic. The manufacturer orauthorized third party can coordinate sale of intravascular devices 102such that devices with new serial numbers are sold to sites withclinical systems 510 that have the new software. Additionally,auto-software update can be provided for the clinical system 510, whichallows for additional flexibility in changing the secret key. Abrute-force attack against CMAC and AES-128 is currently held to becomputationally infeasible. Thus, security against forgery can depend onthe security of the secret key 208.

Persons skilled in the art will recognize that the apparatus, systems,and methods described above can be modified in various ways.Accordingly, persons of ordinary skill in the art will appreciate thatthe embodiments encompassed by the present disclosure are not limited tothe particular exemplary embodiments described above. In that regard,although illustrative embodiments have been shown and described, a widerange of modification, change, and substitution is contemplated in theforegoing disclosure. It is understood that such variations may be madeto the foregoing without departing from the scope of the presentdisclosure. Accordingly, it is appropriate that the appended claims beconstrued broadly and in a manner consistent with the presentdisclosure.

While the present disclosure referred to primarily to intravasculardevices, the system disclosed herein is well suited to authentication ofany disposable or limited use device. One skilled in the art willrecognize the application of the principles herein across otherdisciplines.

What is claimed is:
 1. A system for managing use of intraluminal devicesfor placement in a patient's body, the system comprising: a computingdevice configured for communication with an intraluminal device; and amemory in communication with the computing device and the intraluminaldevice, wherein the computing device is configured to: determine whetherfirst security data stored in the memory is authenticated; determinewhether the intraluminal device has been reconditioned; in response todetermining that the first security data is authenticated and that theintraluminal device has not been reconditioned; write use data to thememory, wherein the use data corresponds to a number of authenticateduses of the intraluminal device at a first time and is modified toinclude the first security data specific to one or more authenticateduses; and read the use data written on the memory at a second time todetermine usage of the intraluminal device.
 2. The system of claim 1,wherein the intraluminal device is a disposable device.
 3. The system ofclaim 1, wherein the intraluminal device is a guidewire or a catheter.4. The system of claim 1, wherein the memory is disposed within theintraluminal device.
 5. The system of claim 1, further comprising apatient interface module in communication with and between the computingdevice and the memory.
 6. The system of claim 3, wherein the cathetercomprises at least one selected from the group consisting of: an imagesensor, a pressure sensor, a flow sensor, and a combination thereof. 7.The system of claim 1, wherein the computing device is configured, inresponse to determining that the intraluminal device has beenreconditioned, to determine whether second security data stored in thememory is authenticated, wherein the second security data is based onthe first security data and reconditioning data.
 8. The system of claim7, wherein the computing device is configured: in response todetermining that the second security data is authenticated, writereconditioned use data to the memory; and in response to determiningthat the second security data is not authenticated, deny access to thememory.